Industry Seeks Changes to OTC Labeling Reform

NDMA wants an exemption for small packages and adjustments to proposed labeling format.

The Nonprescription Drug Manufacturers Association (NDMA) and another trade group are seeking significant modifications to the standardized labeling format proposed for over-the-counter (OTC) drugs. In a conference call July 9 and in a letter dated July 13, NDMA and the Cosmetic, Toiletry, and Fragrance Association asked FDA to exempt certain products and package sizes from the rule and to make minor adjustments to the proposed labeling format.

"FDA's proposal is the most comprehensive OTC rule ever, involving the broadest scope and greatest extent of OTC label changes [ever required] at one time. . . and at a potentially staggering cost, with no defined public health crisis driving the proposal," the associations wrote. "Such an undertaking requires a special balance to ensure that any further improvements in labeling are made at reasonable cost and timing that match the level of urgency and importance of the issue."

The proposed rule appears in the February 27, 1997, issue of the Federal Register (62 FR:9023—9062). In it, FDA argues that a standardized format would better enable consumers, especially the elderly, to read and understand OTC drug labels and to use the products safely and effectively.

While the industry associations do not oppose the adoption of a standardized labeling format, they do have problems with some of the specifics. They seek the following modifications to the proposal:


  • A minimum five-point type size, instead of six-point.


  • No leading (extra space) required between lines. The proposal calls for one-point leading.


  • Allowance of sans serif type fonts. The proposal calls for Helvetica fonts.


  • The ability to wrap warnings from primary to secondary information panels, which is not allowed under the current proposal.


  • No requirement for a "Medication Facts" heading for the information panel, because it would be inappropriate for cosmetic drug products and would take up too much space on small packages.


  • A three-year, instead of a two-year, window in which to implement the changes.

The associations also call for certain packages to be exempt from the final rule, providing they meet any of the following conditions:


  • The total surface area available to bear labeling (including the principal display panel) is less than 12 sq in.


  • More than 60% of the total surface area available to bear labeling (not including the principal display panel) must be used to satisfy the rule's content requirements.


  • The package bears OTC labeling and is a trial size, a packet, an envelope, or a single-use unit package.

The associations argue that if a package meets one of these criteria and cannot hold the new labeling format printed in a 4.5-point type size, it should be automatically exempt from the rule; manufacturers should not be required to petition FDA for the exemption.

They also ask FDA to exempt products such as antidandruff shampoos and antimicrobial soaps and washes because they are really cosmetics rather than drugs and have never been shown to cause harm from misuse.

Cost is the chief concern driving the industry proposal. "NDMA member surveys on FDA's proposal project a potential cost to industry of [more than] $1 billion due to changes in package dimensions and configurations, i.e., not just labeling changes," the letter states.

The trade groups predict that the current proposal will allow labelers to change about 50% of OTC product labels without significant costs. However, if their proposals are accepted, that figure should increase to 75%, they say.

Lastly, the associations ask FDA to make public its research on the feasibility of the proposal and to invite industry or other interested parties to comment on the proposal before the final rule is published.

For more information, contact Diana M. Hernandez, Center for Drug Evaluation and Research, Div. of OTC Drug Products (HFD-560), FDA, 5600 Fishers Ln., Rockville, MD 20857; 301/827-2222. To contact NDMA, write to 1150 Connecticut Ave. N.W., Washington, DC 20036, or call 202/429-9260.


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